RO132472A0 - Food supplement for reducing gastroesophageal reflux - Google Patents

Abstract

The invention relates to a food supplement for reducing gastroesophageal reflux. According to the invention, the supplement consists of 10...16.5% mixture of medicinal plants selected from Achillea millefolium, Calendula officinalis, Matricaria recutita, Plantago lanceolata and Robinia pseudoacacia, 60...72% ecological cocoa butter, 0.5...2% Hippophae rhamnoides oil, 0.5...2% propolis tincture, 0.4...4% bees wax and 0.5...4% baking soda, the percentage being expressed by mass.

Description

PRODUCT DESCRIPTION AND CLAIMS REQUESTED FOR THE PATENT APPLICATION

FOOD SUPPLEMENT TO REDUCE GASTROESOPHAGIAN REFLUX

The invention relates to a dietary supplement in the form of a chewable non-coated tablet, which can be used with good results in improving gastroesophageal reflux.

The product according to the invention consists of a mixture of 10 ... 16.5% medicinal plants (Achillea milefolium, Calendula officinalis, Matricaria recutita, Plantago lanceolata, Robinia pseudocacia), 60 ... 72% cocoa butter (Butiricum cacao) environmentally friendly, 0.5 ... 2.0% Hippophae rhamnoides oil, 0.5 ... 2% propolis tincture, 0.5 ... 4% beeswax and 0.5 ... 4% sodium bicarbonate, mass percent.

The invention has the following advantages:

- By maintaining the product until it melts in the mouth, a systemic action of the product is ensured, the cocoa butter contributing to the dental protection;

- There were no adverse reactions;

- No data are known regarding the interaction with other drugs;

- The dietary supplement does not contain gluten or lactose;

- The product is easy to administer.

The following is an example of obtaining chewable non-coated tablets to improve gastroesophageal reflux.

Sodium bicarbonate is added over the dried, ground and sieved medicinal plants, the whole mixture being homogenized. It is added to the mixture of melted cocoa butter, melted beeswax and Hippophae rhamnoides oil. After complete mixing of the new mixture, add a tincture of propolis and continue mixing, until a homogeneous mixture is obtained. The final mixture is poured into special silicone molds. The product molds are frozen, and after thawing, the tablets are removed from the molds and added to clean and approved packaging for the food industry, or the pharmaceutical industry.

Packages with tablets are kept in clean and disinfected spaces, at a maximum temperature of 25 ° C and protected from the direct action of the sun's rays.

The tablets have pleasing sensory characteristics, specific to the raw materials used and are administered between 2-4 tablets / day.

to 2017 00786

02/10/2017

THE CLAIMS REQUESTED

RELATED TO THE PATENT APPLICATION

FOOD SUPPLEMENT TO REDUCE GASTROESOPHAGIAN REFLUX

Fats give protection to the hard dental structure. Sodium bicarbonate lowers gastric and saliva pH, leading to remineralization of dental enamel and absorption of natural H2 antihistamines from medicinal plants added to the product, and Achillea milefolium, Calendula officinalis, Hippophae rhamnoides oil, Matricaria recutita, Plantago major and Robinia pseudocacia have antihistamine action, hepatic and capillary protection, anti Gram + and anti Gram -, analgesic.

Natural product for improving the gastroesophageal reflux with oral administration, characterized in that it consists of a mixture of 10 ... 16.5% medicinal plants (Achillea Milefolium, Calendula Officinalis, Matricaria Recutita, Plantago Lanceolata, Robinia pseudocacia), 60 .. .72% organic cocoa butter (Butiricum cacao), 0.5 ... 2.0% Hippophae rhamnoides oil, 0.5 ... 2% propolis tincture, 0.5 .... 4% wax bees and 0.5 ... 4% sodium bicarbonate, percentage by mass. Ingestion form - by maintaining the product until it melts in the buccal cavity, a systemic action of the product is ensured, cocoa butter contributing to dental protection. Packaging - approved vial, provided with seal.

The novelty is represented by the formulation of the dietary supplement to reduce the gastroesophageal reflux, in terms of composition.

03/14/2018 to 2017 00786

O.S.I.M.

REPAIRED BATTERY

DESCRIPTION OF THE INVENTION National deposit no. of 2017 00786 Food supplement to reduce gastroesophageal reflux

The invention relates to a dietary supplement for reducing gastroesophageal reflux, used in medicine and pharmacy. Compositions for alternative products for reducing gastroesophageal reflux are known and which are notified and marketed on the national market as food supplements, products / supplements whose formula is patented by OSIM and scientific articles.

Herbal products made in Romania, or manufactured in other countries and marketed in our country, are:

- Reglacid - Hofigal, 60 capsules [1, 6] with one capsule composition: contains powder of 60.00 mg of sea buckthorn fruit (Hippophae fructus), 50.00 mg of cuticle in bird pipette, 60.00 mg of chamomile flower (Chamomillae flos), 52.00 mg ringworm (Hyperici herba), 52.00 mg amaranth (Amaranthus caudatus herba), 1.2 mg volatile thyme oil (Thymi vulgaris aetheroleum), 0.8 mg volatile lavender oil (Lavandulae aetheroleum) and excipients (lactose, polyvinylpyrrolidone K30, magnesium carbonate, talc, magnesium stearate) up to 400.00 mg. Action: Product intended to supplement the diet for the properties: antiseptic, anti-inflammatory in the gastrointestinal tract; improving the symptomatology of some gastrointestinal disorders and reducing the risk of complications and progression to more severe forms; the product regulates gastric acidity, improves digestion, protects the gastrointestinal mucosa and stimulates its regeneration; purifying, slightly laxative and diuretic. There are no claims regarding the effectiveness check in a clinical trial. Administration: 1-2 capsules 3 times a day or 2 tablets 2 times a day, 10-15 minutes before the meal depending on the stage and nature of the digestive disorder or at the recommendation of the doctor evaluating the dose and the rate of administration. Storage conditions: Store at room temperature (15 - 25 ° C), away from moisture and light, in the original packaging! Manufacturer: Hofigal, Romania.

- Gastracid Dl00, 63 chewable tablets - Fares [2] with composition: clay, chamomile flowers (Matricariae flos), soft chamomile flower extract (Matricariae flos), soft extract of softwood root (Liquiritiae radix), tincture of propolis, rhizomes (Calami rhizoma), phenolic essential oil (Phenolic aetheroleum), peppermint essential oil (Menthae aetheroleum), excipients (filler: cellulose, starch, anti-caking agent: talc) [2]. Action: Gastracid tablets (clay, chamomile flowers, soft chamomile flower extract, soft root extract of sweet wood, tincture of propolis, rhizome of obligate, fennel essential oil, peppermint essential oil) helps to neutralize gastric acid with reducing discomfort and unpleasant sensations from the gastroesophageal level; protects the lining of the stomach and esophagus and

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I O.S.I.M. I

I MU EEFORMULATA I promotes a healthy digestive tract. There are no claims regarding the effectiveness check in a clinical trial. Administration: Take one tablet 3 times daily 30 minutes before a meal or as needed. Manufacturer: Fares, Romania.

- Healthy Stomach (Ulcerophyte) 7 Cps Fares [3] with composition / capsule: yellow flowers (Calendulae flos) 40mg, leaf leaves, (Plantaginis folium) 40mg, thyme grass (Mycelis muralis herba) 40mg, ringworm (Hyperici herba) 4hmg, hyssop (Hyssopi herba) 20mg, softwood root (Liquiritiae radix) 20mg. Action: This product acts synergistically through several mechanisms. It reduces the inflammation of the gastric mucosa by faradiol present in the yellows, the active substances of patagina and thyme grass (chlorogenic, neochlorogenic acid, apigenin), glyciretic acid from the root of sweet wood, the amentoflavones from the ringworm and through the essential oil from the isop. It favors the healing of mucosal erosions and increases the secretion of mucus with gastric protective role through carotenoids, mucilages, chlorogenic and neochlorogenic acid from the composition of galbenelelo and patagagine. Thief grass is a traditional remedy used to heal ulcers. To these are added the antispastic and soothing action of stomach pains due to the active principles of thief grass, yellows and sweet wood root. Clinical studies: Following the study performed at the Medical Clinic III Cluj-Napoca, it has been shown that HEALTHY STOMAC is an effective preparation in the treatment of peptic disorders (gastritis and erosive duodenitis, duodenal ulcers). Administration: Children 6-14 years: 1 capsule 3 times daily; Adults: 2 capsules 3 times daily. The administration is done 15 minutes before the main meals. The duration of a cure is 46 weeks, or as recommended by the doctor. Manufacturer: Fares, Romania.

- DGL 500 plus - 760 mg - 100 chewable tablets [4] with the licorice composition (Glycyrrhiza glabra) deglicirizinate (from root) 4: 1 - 380 mg. Action: Licorice (sweet wood) stimulates both mucin secretion and the development of new mucosal cells by increasing blood flow to the cells of the stomach wall. At the same time, studies have shown that licorice is effective in inhibiting the replication of harmful intestinal bacteria such as Helicobacter pylori. Clinical Trials: A double-blind placebo study concluded that 16 people with severe stomach disorders had an average improvement of 78% after 360 mg of DGL 3 times daily (on the 3 main meals). Another study concluded that DGL administered at 760 mg 3 times daily is just as effective as allopathic drug (Tagamet) (cimetidine) without any side effects. Administration: Recommended mode of administration (adults only, orally): 1-2 tablets a day 20 minutes before eating. It will chew well in the mouth with saliva before swallowing. Manufacturer: Organica Health Products.

- Sun Wave Topacid 100 caps [5] with the composition: Glycyrrhiza glabra - 53.30 mg, Asparagus racemosus - 33.32 mg, Tinospora cordifolia - 33.32 mg, Roşa centifolia - 6.66 mg. Action: Efficient control of the symptoms of hyperacidity (burns, pain, nausea, acid itching, vomiting, etc.). Topacid administration is not accompanied by adverse reactions, even in long-term use (such as malabsorption, maligestion, constipation, headache, gastrointestinal tract infections). When discontinuing Topacid therapy, no secretory rebound occurs. It does not produce hypo- or hydrochloride, even in long-term administration. There are no claims regarding the effectiveness check in a clinical trial. Administration: 2 capsules Topacid, three times a day

O.S.I.M.

REPLACED ROW

03/14/2018 a 2017 00786 day, after meals, in acute phase; 1 capsule Topacid, 2-3 times daily, in the maintenance phase. Manufacturer: Sun Wahe Pharma.

Patented products / supplements at OSIM are:

- No. Patent 00122016: Natural nutritional supplement for the regulation of gastric secretions and improvement of digestion, in the form of tablets or capsules, consisting of Plantago lanceolata powder, Amaranthus caudatus powder, Hippophae rhamnoides fruit pulp, Glycyrrhiza paste glabot powder, Glabot paste , volatile oils of Lavandula officinalis, Thymus vulgaris, Foeniculum vulgare, Meniha piperita and pharmaceutically acceptable excipients;

- No. Patent 00121764 - Bioactive product, with anti-ulcerative action, and process for obtaining it, which contains polysaccharides, flavones, polyphenolcarboxylic acids, proteins and minerals.

- No. Patent 00122072 - Opofitotherapeutic product, intended for the regulation and protection of the digestive and liver functions, in the form of chewable tablets or capsules, for the regulation and protection of the digestive and hepatic functions, which is made up of chicken cuticle powder, stabilized by the hydrolysis system, and the powder of the plant Sylibum marianum - Armurariu, family Asteraceae, together with pharmaceutically acceptable excipients.

Scientific article: Abdel-Aziz H, Zaki HF, Neuhuber W, et al. Effect of an herbal preparation, STW 5, on an acute model of reflux oesophagitis in rats. J Pharmacol Sci. 2010; l 13 (2): 134-142 - in which the trade name of the preparation STW5 is Ibetogast® and comprises Angelica archangelica, Matricaria chamolilla, Cuminun cyminum, Mentha piperita, Glycyrrhiza glabra, etc.

The solutions presented in the prior art have the following disadvantages:

No solution addresses dental erosions, a common symptom in gastroesophageal reflux disease;

- Certain solutions contain synthetic substances (polyvinylpyrrolidone K 30);

- Not all the solutions presented contain ingredients with systemic antacid role with rapid action, although they are recommended to be used if necessary;

- There are technical solutions presented that contain allergenic substances, such as lactose.

The technical problem that the invention solves is to establish the natural components and association reports within a food supplement type product used to reduce gastroesophageal reflux.

The dietary supplement according to the invention eliminates the mentioned disadvantages by the fact that it consists of 10 ... 16,5% medicinal plant mixture, in association ratio: 7 ... 9% Achillea milefolium, 50 ... 56% Calendula officinalis, 10 ... 13% Matricaria recutita, 10 ... 13% Plantago lanceolata and 10 ... 13% Robiniapseudocacia from all the plants used, 60 ... 72% organic cocoa butter, 0.5 ... 2% oil Hippophae rhamnoides, 0.5 ... 2% propolis tincture, 0.4 .. .4% beeswax and 0.5 .. .4% sodium bicarbonate.

By applying the invention, the following advantages are obtained:

- Synergistic effect on both the oral cavity and the stomach:

- Systemic action, cocoa butter being an adjuvant in dental protection;

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O.S.L 1.

REFOCULATED ROW

- Remineralization of the tooth enamel and stimulation of the absorption of natural H2 antihistamines, due to the sodium bicarbonate which increases the pH in the oral cavity;

- It is natural and easy to administer;

- Contains no preservatives, gluten, lactose, or other synthetic substances;

- No side effects;

It reduces the total number of reflux episodes 24 hours, the number of reflux episodes over 5 minutes and the longest reflux time.

Because dental erosions are a common symptom of gastroesophageal reflux disease, this extraesophageal manifestation of this disease needs to be addressed. According to the prior art, no product / supplement is acting on the protection of the dental structure.

The therapeutic effect of dietary supplementation to reduce gastroesophageal reflux is due to antihistamine action, prostgandins, gastrointestinal protection, liver protection, hair protection, analgesic action, anti-microbial action - anti Gram + and anti Gram - [6,7].

The dietary supplement to reduce gastroesophageal reflux is in the form of uncoated tablets. By maintaining in the oral cavity until it melts, it acts systemically, orally, cocoa butter being an adjuvant in dental protection. Sodium bicarbonate increases the pH in the oral cavity, contributing to the remineralization of tooth enamel and stimulates the absorption of natural H2 antihistamines.

The following is a detailed description of the food supplement for reducing gastroesophageal reflux:

Medicinal plants Achillea milefolium 1.5%, Calendula officinalis 9%, Matricaria recutita 2%>, Plantago lanceolata 2% and Robinia pseudocacia 2%, dry mass percentages are ground, sieved and mixed. To the mixture of all the ground and sifted plants, add 4% sodium bicarbonate which is homogenized with it. The 71.5% cocoa butter melts at a maximum temperature of 38 ° C. Add 4% beeswax to the melted butter and mix continuously until it is melted and a homogeneous mixture is formed. Hippophae rhamnoides 2% oil is added to this mixture and completely homogenized. After complete homogenization, add the mixture of medicinal plants and bicarbonate, then continue the homogenization until a homogeneous mixture is formed. Over this new mixture is added 2% propolis tincture and homogenized until a final homogeneous mixture is formed. The final mixture is poured (dosed) into special silicone molds. The product molds are frozen, and after freezing, the tablets are removed from the molds and added to clean and approved packaging for the food industry, or the pharmaceutical industry. Packages with tablets should be kept in clean and disinfected spaces, at temperatures up to 25 ° C and away from direct sunlight, or other sources of heat.

The results of the clinical study indicated the reduction of the total number of reflux episodes 24 hours, the number of reflux episodes over 5 minutes and the decrease of the longest reflux.

O.sj./ui.

REFORMULATED ROW

03/14/2018 to 2017 00786 (min.). The clinical study was conducted within the Medical Clinic II, Str. Clinics 3-5, on a batch of 26 patients, according to the national legislation in force.

The product is natural, easy to administer. It does not contain preservatives, gluten, lactose, or other synthetic substances and has not had any adverse reactions. The dietary supplement for reducing gastroesophageal reflux comes in the form of uncoated tablets, with a yellowish green color, specific to the raw materials used, pleasant odor, specific to the components and taste of bitter, pleasant, specific to the components. The product subject to the invention has a melting point between 36 - 37 ° C and is microbiologically safe: Yeasts and molds / g: <10 ufc / g; Listeria monocytogenes: Absent / g; Enterobacteriacee: 300 ufc / g. The food supplement to reduce gastroesophageal reflux is stored in clean, sanitized and disinfected spaces, away from heat sources and direct action of the sun's rays with a maximum temperature of 25 ° C and relative humidity of 75% air. The product subject to the invention is transported in clean, sanitized means of transport and with a maximum temperature of 25 ° C. It does not pollute the environment and as a result no special precautions are required for waste disposal.

The tablets are given between 2-4 tablets / day, after meals, or when needed.

O.S.I. Λ |

REFQRMUUT I Row

03/14/2018 to 2017 00786

REFERENCES

National deposit no. of 2017 00786 Food supplement to reduce gastroesophageal reflux

ELECTRONIC REFERENCES:

[1] https://www.pcfarm.ro/produs/3976/Reglacid—Hofigal:

[2] https://fares.ro/gastric-natural dressing/ r31https: //www.leaculverde.ro/supplement//digestive/stomac-sanatos-ulcerofit-70cps-fares13871.html r41http: //www.producedproved .ro / products / natural-organic-products / dgl-500-plus-760-mg-100 chewable tablets / [5] https://www.mattca.rO/sun-wave-topacid-100caps.html#.WphtGmpubIU [6] https://phvtochem.nal.usda.gov/phytochem/search

BIBLIOGRAPHICAL REFERENCES:

[7] Hațieganu E, Stecoza CE, Pharmaceutical Chemistry, Tenth Edition, Medical Publishing House, 2013, Bucharest, pp. 381 ... 383.

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Claims (1)

National deposit no. of 2017 00786 Food supplement to reduce gastroesophageal reflux The invention relates to a dietary supplement for reducing gastroesophageal reflux. The supplement, according to the invention, consists of 10 to 16.5% by weight of a mixture of medicinal plants chosen from Achillea milefolium, Calendula officinalis, Matricaria recutita, Plantago lanceolata and Robinia pseudocacia, 60 ... 72% organic cocoa butter , 0.5 ... 2% Hippophae rhamnoides oil, 0.5 ... 2% propolis tincture, 0.4 ... 4% beeswax and 0.5 ... 4% sodium bicarbonate.